Remibrutinib

Novartis on Thursday upped peak sales estimates for two of its key cancer drugs, Kisaqali and Scemblix, which together are now forecast to bring in revenue of at least $14 billion. The upgrade for the two products came alongside the company disclosing new mid-term guidance, which sees annual sales growth in the range of 5% to 6% on a constant currency basis between now and 2030 — previously, growth of 6% annually was expected from 2024 to 2029. CEO Vas Narasimhan said "we expect to sustain…momentum over the next five years, driven by assets we already have in hand as well as upcoming launches with multi-billion-dollar sales potential." According to the drugmaker, it now has eight derisked assets on the market that each have peak sales potential of between $3 billion and $10 billion — Kisqali, Cosentyx, Kesimpta, Pluvicto, Scemblix, Leqvio, Fabhalta and Rhapsido. These are forecast to more than offset the impact from generic erosion through 2030, from competition to products such as Cosentyx, Entresto and Tasigna.For Kisqali, peak sales are expected to be at least $10 billion, up from an earlier estimate of $8 billion, while revenue from Scemblix is seen reaching at least $4 billion, lifted from $3 billion previously.Beyond its launched medicines, Novartis said Thursday that it expects at least 15 potentially submission-enabling clinical readouts over the next two years. These include: ianalumab; Ac-PSMA-617; OAV101 IT; pelacarsen; del-desiran and del-brax.

iStock, Artem_Egorov With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive. Last year, biotech executive and entrepreneur Andrew Pannu told BioSpace that immunology and inflammation could be a particularly attractive therapeutic space because of its “pipeline-in-a-product” potential. It’s a playbook many biopharma companies—including Novartis and Vertex—appear increasingly keen to operate by. In one of 2024’s biggest acquisitions—and Vertex’s largest-ever—the Boston-based pharma subsumed immunotherapy player Alpine Immune Sciences and its lead asset povetacicept for $4.9 billion. A dual antagonist of the BAFF and APRIL cytokines for autoimmune and inflammatory diseases, povetacicept is currently being studied in Phase III and Phase II/III trials for IgA nephropathy (IgAN) and primary membranous nephropathy, respectively, and Vertex said in a press release last month that it has “pipeline-in-a-product potential across a range of B cell–mediated diseases.” This is also a strategy echoed in the immunology and inflammation (I&I) space by Novartis, which recently presented Phase III data for ianalumab in Sjögren’s disease at the American College of Rheumatology Convergence congress. If approved, it would be the first targeted treatment for this common rheumatic autoimmune disease. But Novartis isn’t stopping there. Ianalumab, a B cell–depleting antibody that, like povetacicept, targets the BAFF receptor, is also in mid- to late-stage development for systemic lupus erythematosus (SLE), lupus nephritis and systemic sclerosis as well as earlier-stage development for three hematological indications. “We’ve had this common theme around saying that when we understand a drug and its mechanism of action, we will evaluate it in multiple indications simultaneously,” Shreeram Aradhye, president of development and chief medical officer at Novartis, told BioSpace last month. The company took the same approach, Aradhye said, with remibrutinib, which was approved by the FDA in September as Rhapsido, the first BTKi drug for chronic spontaneous urticaria (CSU). Elsewhere in the pipeline, the company is also studying remibrutinib in pediatric chronic spontaneous urticaria, hidradenitis suppurativa, multiple sclerosis and food allergy, among other indications. “Having an asset where we understand the mechanism of action, making sure that we garner its full value by evaluating it in multiple places where it could help in ambitious parallel programs that are being run, has also worked out well for us,” Aradhye said. Biogen, too, has spent big money to expand its presence in I&I. In May 2024, the big biotech snapped up Human Immunology Biosciences , aka HI-Bio, for up to $1.8 billion. At the center of the deal was felzartamab, whose mechanism of selectively depleting CD38+ cells could give Biogen “applicability across a range of immune-mediated diseases,” BMO Capital Markets analysts wrote in a note to investors at the time. With the global immunology market projected to exceed $257 billion by 2032, it’s no wonder so many companies are looking to optimize their shots on goal. Proof Is in the Market If I&I–focused companies need additional incentive to embark on this strategy, they need look no further than AbbVie. In the third quarter, the company’s two-headed immune blocking behemoth—made up of Skyrizi and Rinvoq—brought in nearly $7 billion combined, accounting for almost half of AbbVie’s income for the quarter. Together, the two drugs cover a host of immune-mediated diseases. Skyrizi is indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, while Rinvoq is approved to treat rheumatoid arthritis, atopic dermatitis and ankylosing spondylitis. Rinvoq’s reach could soon expand further, with recent successful Phase III data in alopecia areata and vitiligo . And of course, Skyrizi and Rinvoq are successors of AbbVie’s Humira—which long held the title of the world’s top-selling drug. The blockbuster held FDA approvals in upwards of 15 autoimmune and inflammatory diseases since its initial greenlight for rheumatoid arthritis in 2002 . In an interview with BioSpace , Graig Suvannavejh, managing director of Equity Research at Mizuho Securities, pointed to another prime example of I&I single product success: Sanofi and Regeneron’s Dupixent . A dual inhibitor of IL-4 and IL-13 signaling, Dupixent is approved in the U.S. to treat eight inflammation-driven diseases, including atopic dermatitis, chronic obstructive pulmonary disease and asthma. In the third quarter, Sanofi reported €4.2 billion ($4.8 billion), the first time the antibody has exceeded the €4 billion mark in a single quarter. Earnings AbbVie’s Immunology Dyad Dominates Again in Q3 Skyrizi and Rinvoq made nearly $7 billion combined, almost half of the company’s income for the quarter alone. October 31, 2025 · 2 min read · Dan Samorodnitsky Build a ‘Better Mousetrap’ While the pipeline-in-a-product strategy is leveraged across other therapeutic spaces—think Keytruda in oncology—I&I presents a unique opportunity, experts told BioSpace . “The key thing about immunology is that a lot of these diseases . . . they present with very, very different symptomatology, and what the cause of the disease is and what autoantibodies involved are all different, but there are centralized mechanisms that you can leverage with a single product,” said Myles Minter, biotech analyst and partner at William Blair. A company can prove safety in one indication, he continued, “and then expedite the development as a pipeline in a product in subsequent indications.” Further, Minter said, once these pathways are established, the opportunity exists to improve upon original drugs with next-generation models. “You’ve also got this pathway that’s been set by predecessor compounds, that the biology actually plays out. It’s just, can you do it in a better way? And that’s where we’re seeing all these next-generation therapies come through.” Minter offered the example of Roche’s Rituxan (rituximab), first approved for non-Hodgkin lymphoma in 1997, and for a variety of other cancers and inflammatory diseases since. Minter described Rituxan as “quite a brutal therapy.” He explained, “It will deplete your B cells, but it is efficacious when it works.” Now, on the B cell modulation side, Vertex and other companies are focused on candidates such as povetacicept that inhibit BAFF and APRIL—two targets expressed on the various B cells responsible for autoantibody production in many autoimmune diseases. Novartis’s ianalumab also targets the BAFF receptor. It’s a strategy that has worked before. Suvannavejh pointed out that Humira was not the first drug to block tumor necrosis factor (TNF)—it was just the most effective. Humira was preceded in the market by J&J’s Remicade and Amgen’s Enbrel, “but . . . it’s really Abbott and then AbbVie that kind of perfected the model, and I think they just had a better mousetrap for blocking TNF alpha.” The range of diseases that can be targeted in I&I is also quite broad, Minter noted. “Inflammation and immunology spans a lot of different indications, and it gives you an option to go either after very prevalent diseases,” such as atopic dermatitis and plaque psoriasis. “Or you can go into increasingly rare disease opportunities,” where he sees Vertex and Biogen heading with their respective pipelines. Of course, no matter how plentiful the opportunities—or the company’s cash on hand—it is important to be “somewhat capital efficient,” Minter said. “You can’t just put a drug into every single indication that comes in your head and do it all at once.” On that note, there are key indications the biggest players are prioritizing. Minter highlighted IgAN, the lead indication for povetacicept. Novartis won FDA approval last year for Fabhalta, the first complement inhibitor for the reduction of proteinuria in primary IgAN . Suvannavejh, meanwhile, pointed to atopic dermatitis, rheumatoid arthritis, psoriasis, asthma, chronic obstructive pulmonary disease (COPD) and ulcerative colitis. For Suvannavejh, the common theme between Humira and Dupixent and similar drugs is that they broadly target common pathways of inflammation across the skin, gastrointestinal and other organ systems. “There are X number of cellular cytokines and mediators of inflammation, and if you can find that widget that can block inflammation, then you have the potential of working in lots of different conditions,” he said, “because inflammation is everywhere.” Business 5 Biotechs Taking the Pipeline-in-a-Product Approach to Drug Development The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges. August 20, 2025 · 10 min read · Tristan Manalac